System and method for preventing wrong-site surgeries

ABSTRACT

A container holds at least one surgical implement, has a lock mechanism, and has a signature label that impedes access to the surgical implement until the correct surgical site is confirmed. A method of using the container includes the steps of confirming the correct surgical site, signing the label and removing it from the container, placing the label in the medical record, unlocking the container, removing the implement, and beginning the surgery, wherein the surgical team is forced to pause to confirm the correct surgical site before starting the surgery. The system and method may also include a wrong site surgery profile used by individuals within the surgical procedure environment and third parties for tracking and determining if, and where, a wrong site surgical procedure occurred. The profile can be updated, tacked and monitored while a patient is interacting within the medical environment.

CROSS-REFERENCE TO RELATED APPLICATION

In accordance with 37 C.F.R 1.76, a claim of priority is included in anApplication Data Sheet filed concurrently herewith. Accordingly, thepresent invention claims priority as a continuation of U.S. patentapplication Ser. No. 14/873,974, entitled “SYSTEM AND METHOD FORPREVENTING WRONG-SITE SURGERIES” filed Oct. 2, 2015, which is acontinuation-in-part of U.S. patent application Ser. No. 14/143,920,entitled “SYSTEM AND METHOD FOR PREVENTING WRONG-SITE SURGERIES” filedDec. 30, 2013, now U.S. Pat. No. 9,168,107 issued Oct. 27, 2015, whichis a continuation-in-part of U.S. patent application Ser. No. 11/270,686entitled “SYSTEM AND METHOD FOR PREVENTING WRONG-SITE SURGERIES”, filedNov. 9, 2005, now U.S. Pat. No. 8,616,215 issued Dec. 31, 2013, whichclaims priority to U.S. Provisional Patent Application No. 60/626,240,filed Nov. 9, 2004, entitled “SURGERY START BOX”. The contents of eachof the above referenced applications are herein incorporated byreference in its entirety.

TECHNICAL FIELD

The present invention relates generally to surgical devices andprocedures and, in particular, to surgical devices and procedures forpreventing wrong-site surgeries.

BACKGROUND OF THE INVENTION

A great deal of attention has recently been given to the unacceptablerate of avoidable patient injuries, or so-called medical mistakes, inthe United States. Estimates of the number of medical mistakes per yearin the United States is difficult to ascertain, but a recentpublication, To Err is Human, by Dr. Lucian Leape, suggests that theavoidable death rate for medical mistakes are between 48,000 and 96,000patients per year.

As defined by the Joint Commission on Accreditation of HealthcareOrganizations (JCAHO), wrong-site surgery includes wrong side or site ofthe body, wrong procedure, and wrong-patient surgeries.

Prevalence of Wrong-Site Surgery

From January 1995 to March 2001, JCAHO reviewed voluntary reports of1,152 “sentinel events.” Wrong-site surgery accounted for 114 cases(9.9%) and included procedures in neurosurgery, urology, orthopedics,and vascular surgery. Despite the high profile of JCAHO's Sentinel EventPolicy, under-reporting by healthcare organizations likely affects thesestatistics. Only 66% of the 1,152 total events were “self-reported” bythe institutions involved; the balance coming from patient complaints ormedia stories. Using a mandatory reporting system, the New York StateDepartment of Health received 46 reports of wrong-site surgery from Apr.1, 1998 through Mar. 31, 2000, compared with 114 cases JCAHO receivednationally over a period 3 times longer. This suggests that voluntaryincident reporting may grossly underestimate the true incidence ofwrong-site surgery by a factor of 20 or more.

The Physician's Insurance Association of America (PIAA) reviewed theclaims data from 22 malpractice carriers representing 110,000 physiciansfrom 1985 to 1995. There were 331 cases of wrong-site surgery. Thecomplete PIAA database documents almost 1,000 closed malpractice claimsinvolving wrong-site surgery. However, this figure also likelyunderestimates the prevalence of wrong-site surgery. Since mostwrong-site surgeries involve relatively minor procedures (arthroscopy,rather than limb amputations or major neurosurgical procedures),sequelae are minimal and may not result in a claim. Consequently,estimates of the incidence of wrong-site surgery derived from litigationdata likely underestimate the true prevalence of this problem, as doestimates based on incident reports.

Factors Identified as Contributing to Wrong-Site Surgery

Several factors have been identified that may contribute to an increasedrisk of wrong-site surgery. These risk factors include:

-   -   More than one surgeon involved in the case, either because        multiple procedures were contemplated or because the care of the        patient was transferred to another surgeon;    -   Multiple procedures were conducted on the same patient during a        single trip to the operating room, especially when the        procedures were on different sides of the patient;    -   Unusual time pressures related to an unusual start time or        pressure to speed up the preoperative procedures; and    -   Unusual patient characteristics such as physical deformity or        massive obesity that might alter the usual process for equipment        set-up or positioning of the patient.

The root causes identified by hospitals were most often related tocommunication, preoperative assessment of the patient, and theprocedures used to verify the operative site. Communication issues fallinto two major categories:

-   -   Failure to engage the patient (or family, when appropriate) in        the process of identifying the correct surgical site, either        during the informed consent process or by the physical act of        marking the intended surgical site; and    -   Incomplete or inaccurate communication among members of the        surgical team, often through exclusion of certain members of the        team (e.g., surgical technicians) from participation in the site        verification process, or through reliance solely on the surgeon        for determining the correct operative site.

The completeness of the preoperative assessment of the patient was afrequent contributing factor, often through failure to review themedical record or imaging studies in the immediate preoperative period.The procedures for verifying the correct operative site were found to beflawed in many cases due to:

-   -   No formal procedure;    -   No final check in the operating room;

The absence of any oral communication in the verification procedure;

-   -   All relevant information sources not available in the operating        room;    -   No checklist to ensure all relevant information sources were        checked;    -   Some members of the surgical team were excluded from the        verification process and felt they were not permitted to point        out a possible error; and    -   Total reliance on the surgeon for verifying the surgical site.

JCAHO Strategies for Reducing Wrong-Site Surgery

The Joint Commission offers the following possible strategies forreducing the risk of wrong-site surgery:

-   -   Clearly mark the operative site and involve the patient in the        marking process to enhance the reliability of the process;    -   Require an oral verification of the correct site in the        operating room by each member of the surgical team;    -   Develop a verification checklist that includes all documents        referencing the intended operative procedure and site, including        the medical record, X-rays and other imaging studies and their        direct observation of the marked operative site on the patient;    -   Personal involvement of the surgeon in obtaining informed        consent;    -   Ensure through ongoing monitoring that verification procedures        are followed for high-risk procedures; and    -   “Time out” immediately before starting the procedure. (Source:        Joint Commission on Accreditation of Healthcare Organizations.        Sentinel Event Alert, issue six, Aug. 28, 1998.)

Despite the implementation of strategies to prevent wrong patient, wrongsite, wrong side surgery, regrettably this seemingly most preventable ofcomplications still occurs. (The aforementioned statistics do notaddress the number of times in which implants or instrumentation isgoing to be placed as a part of the procedure, and are not availablewhen the surgeon is ready for them. In these instances, the surgeon musteither change plans, or wait while the surgical team attempts to locatethe appropriate implants or instrumentation, which, in some instances,is located at another hospital.) The incorrect assumption of a medicalprofessional's infallibility, coupled with organized medicine's focus onthe individual's medical mistakes rather than a systems approach havecontributed to this problem. In an attempt to improve patient safety,“[e]ffective Jul. 1, 2004, compliance with the Universal Protocol forPreventing Wrong Site, Wrong Procedure, Wrong Person Surgery will berequired of all Joint Commission accredited organizations.” As a part ofthe universal protocol, a “pause” or “time out” is required. This servesas a final verification of: (1) the correct patient; (2) the correctprocedure, site and side; and as applicable, (3) the availability ofimplants or instrumentation, prior to making incision. This is a timewhen all members of the surgical team are supposed to pause to reviewthe case, and agree that the correct procedure is being done on thecorrect patient, at the correct site, and on the correct side. Intheory, this would ensure that any errors that had been made could bedetected prior to incision. In reality, the “time out” seldom occurs;and when it does, not in any uniform or regular manner. Without auniform or regular procedure, ritualized compliance, i.e. going throughthe motions results in many institutions. The universal protocol cannotenforce a pause and does not specify a protocol as to what should happenduring a pause. The universal protocol does not specify a particulartime for the pause to occur, and it does not specify a protocol as towhat should happen during the pause, that is to say, what informationshould be communicated by whom, and to whom. While guidelines may besuggested, each institution determines how to comply, thereforestandardization is not achieved.

Accordingly, it can be seen that a need exists for improvements tosurgical procedures and devices to prevent or at least reduce wrong-sitesurgeries. It is to the provision of meeting these and other needs thatthe present invention is primarily directed.

SUMMARY OF THE INVENTION

Generally described, the present invention provides a system and methodfor preventing wrong-site surgeries by imposing a pause just before thesurgery starts, during which time the surgical team conducts apre-operative assessment to confirm that correct site of the surgeryabout to be performed. By imposing the pre-operative assessment, thesurgical team gets one last chance to catch any avoidable mistake thatwould otherwise lead to a wrong-site surgery.

In a first example embodiment of the present invention, the systemincludes a container that holds one or more surgical implements, a lockmechanism for securing the container closed, and a removableconfirmation label that blocks or at least impedes access to the lockmechanism. The surgeon cannot readily open the container to get thesurgical implements until the correct surgical site has been confirmedand the label has been removed. The surgical implements include one ormore scalpels or other blades, a syringe loaded with a local anesthetic,a needle, a scope, and/or other surgical implements needed at the outsetof the surgery. The label includes, for example, a checklist forconfirming surgery-related information and one or more fields forsignatures.

In one aspect of the invention, the lock mechanism includes a lockmember that fits through two openings in the container that align whenthe container is closed. Preferably, the container includes a bottom anda top that slides off the bottom, with one lock opening being throughthe top, and the other lock opening formed into an internal divider wallthat also defines compartments for the surgical implements.

In another aspect of the invention, the container bottom has one or morededicated compartments for surgical needles. In use, the bottom may bepositioned beside a surgical team member for storing surgical needlesafter they have been used in the surgery. Then, at the conclusion of thesurgery, the container may be closed and the surgical sharps all safelydisposed of at once.

In yet another aspect of the invention, the container top can be removedfrom the bottom and positioned between the surgeon and a surgical teammember to define a neutral zone where hands do not meet. With theneutral zone clearly defined, the incidence of stickings when passingthe surgical sharps back and forth is reduced.

In another aspect of the invention, the container can be adapted to betracked and/or monitored using, for example, a data capture and/ordisplay device, system or technology secured to at least one portion ofsaid container.

In another aspect of the invention, the container can be adapted toprovide a quick and easy visualization mechanism to relate to thesurgical team the correct site, i.e. left side or right side, thesurgical procedure should occur.

In another aspect of the invention, systems and methods which utilize aphysical device to implement and enforce a universal standard areprovided. Applicant's methods and systems are the first to track aseries of data points which can be analyzed to provide wrong sitesurgery near miss data and wrong site surgery error data. Such trackingand data collection enables an institution to improve their processeshandling wrong site surgeries with objective data, relevant to their owninstitution.

In another aspect of the invention, a system and method of consistentlyproducing, capturing, and storing reliable and data mineable wrong sitesurgery data is provided. The systems and methods include electronicwrong site surgery near miss data or electronic wrong site surgery errordata, or an electronic patient surgical profile. The systems and methodsmay be utilized to support organizational and governmental processimprovement initiatives to greatly reduce and prevent wrong-sitesurgeries across hospital systems.

In use, the system forces a surgery team to pause prior to initiatingthe surgery, after the patient is draped and the surgeon and surgicaltechnician are both sterilely gowned, when all members of the surgicalteam pause to make sure that they have the correct patient, the correctoperation is being performed, on the correct site and side, and allnecessary surgical instrumentation or implants are physically available.Once that information is confirmed, which might require the surgeon toreview the medical record or the imaging studies; the surgeon removes adual-tipped pen from the top of the container and uses the ink side tosign the label on the box. The label is then removed and placed in themedical record, and the surgeon now has access to the lock to open thecontainer and remove the surgical implement(s). The surgical marking penside of the pen can be used to mark the incision. The container top isthen turned upside down and serves as the surgical neutral zone, whichdefines a hands-free “neutral zone” where sharp instruments can betraded between the surgeon and surgical technician without the actualpassing of sharp instruments from hand to hand. In addition, thecontainer may also have pre-loaded local anesthetic with a needle andsyringe, to further expedite the starting of the operation. Furthermore,compartments in the container will have foam padded areas, with printednumbers, for the counting and storage of suture needles, as well asother sharps, and at the end of the surgical case the container can bereclosed securely, with all the sharps in the container accounted for,and safely disposed of as one unit.

In a second example embodiment, the container bottom has fourcompartments with a shorter syringe compartment. In a third exampleembodiment, the label is attached to the top and bottom of the containerto lock it closed, so that the label doubles as the lock. In a fourthexample embodiment, the lock member is provided by a tie member thatfits through aligned openings formed by two external tabs on thecontainer, and the label covers the lock member. In a fifth exampleembodiment, the lock member is provided by a wrapper that encloses thecontainer, and the label is removably attached to the wrapper or to apull tab for opening the wrapper. And, in still other embodiments, thecontainer does not include a lock mechanism, or it does include a lockmechanism and the label does not cover it, but the label impedes accessto opening the container by being prominently positioned so that it ishard not to notice it, which prompts a pause for the surgical team toconduct the pre-operative assessment to confirm the correct site of thesurgery.

The method of preventing wrong-site surgery comprises the steps ofproviding a container that holds a surgical implement and has a labelfor confirming surgery-related information, with the label removablyattached to the container; using the label to conduct a pre-operativeassessment confirming a correct surgical site; removing the label fromthe container; opening the container and removing the surgicalimplement; and using the surgical implement at the outset of thesurgery. In this way, the pre-operative assessment confirming that thecorrect surgical site has been identified is done before making anincision and starting the surgery. Preferably, the container is providedwith a lock mechanism securing it closed, and the label is positionedblocking access to the lock mechanism so that the label must be removedto open the container.

In one aspect of the method, the container includes a top that isremoved to open the container. The method further includes the steps ofpositioning the removed container top between a surgeon and a surgicalteam member to define a neutral zone where hands do not meet; andexchanging surgical sharps between the surgeon and the surgical teammember without sticking each other. The exchanging is done by thesurgeon placing the surgical sharps into the container top and thesurgical team member then picking them up, and vice versa.

In another aspect of the method, the container includes a bottom with atleast one compartment that holds the surgical implement and with one ormore additional compartments for surgical needles, and positioning theremoved container bottom beside a surgical team member. The methodfurther includes the steps of, after the surgical needles have been usedin the surgery, storing the used surgical needles in the dedicatedcompartments in the container bottom. In addition, the method includesreplacing the top on the container to close the container at theconclusion of the surgery; and disposing of the container with the usedsharps safely inside.

The specific techniques and structures employed by the invention toimprove over the drawbacks of the prior devices and accomplish theadvantages described herein will become apparent from the followingdetailed description of the example embodiments of the invention and theappended drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a container for surgical sharpsaccording to a first example embodiment of the invention, showing thecontainer in a closed and locked position;

FIG. 2 is a left side view of the container of FIG. 1;

FIG. 3 is a plan view of the container of FIG. 1, showing labels on thecontainer, including a confirmation/signature label covering a lockmember so that the container cannot be unlocked and opened until thelabel is removed;

FIG. 4 is a perspective view of the container of FIG. 1 in an unlockedand open position;

FIG. 5 is a cross section view of the container of FIG. 1 taken at line5-5, showing a lock member being removed from aligned lock openings tounlock the container;

FIG. 6 is a perspective view of the lock member of FIG. 5;

FIG. 7 is a plan view of an instructions label of FIG.

3;

FIG. 8 is a plan view of the confirmation/signature label of FIG. 3;

FIG. 9 is a plan view of a surgical pen-covering label of FIG. 3;

FIG. 10 is a plan view of the container of FIG. 1, ready for use,showing compartments holding a local anesthetic-loaded syringe andsurgical blades for use in the surgery, and empty compartments for usedsuture and syringe needles;

FIG. 11 is a perspective view of the container bottom of FIG. 10 in use,showing the used surgical suture and syringe needles stored in theirdedicated compartments;

FIG. 12 is a schematic diagram of the container shown in FIG. 10 in use,showing the container bottom holding the surgical sharps and thecontainer top inverted and defining a neutral zone between the surgeonand the surgical technician;

FIG. 13 is an exploded perspective view of a container for surgicalsharps according to a second example embodiment;

FIG. 14 is a plan view of the bottom of the container of FIG. 13;

FIG. 15 is a perspective view of a container for surgical sharpsaccording to a third example embodiment, showing the container in aclosed and locked position;

FIG. 16 is a perspective detail view of a container for surgical sharpsaccording to a fourth example embodiment, showing a label being removedto expose a lock;

FIG. 17 is a side view of a container for surgical sharps according to afifth example embodiment, showing a label positioned on a sterile innerwrapping enclosed by an outer wrapping;

FIG. 18 is a plan detail view of the container of FIG. 17, showing anopener strip and pull tab of the sterile inner wrapper;

FIG. 19A is a perspective view of a container for surgical equipmentaccording to an alternative embodiment of the invention, showing thecontainer in a closed position;

FIG. 19B is a perspective view of an alternative embodiment of thecontainer for surgical equipment, illustrating an outer container.

FIG. 20 is a top view of the container of FIG. 19;

FIG. 21 is a perspective view of a container for surgical equipmentaccording to an alternative embodiment of the invention, showing thecontainer having an RFID transponder;

FIG. 22 is a perspective view of a container for surgical equipmentaccording to an alternative embodiment of the invention, showing thecontainer having a data storage device;

FIG. 23A is a perspective view of a container for surgical equipmentaccording to an alternative embodiment of the invention; showing thecontainer having a central control unit;

FIG. 23B is a schematic diagram of the components of an illustrativeexample of a central control unit;

FIG. 24 is a perspective view of a container for surgical equipmentaccording to an alternative embodiment of the invention, showing oneembodiment of a surgical site visual indicator;

FIG. 25 is a perspective view of a container for surgical equipmentaccording to an alternative embodiment of the invention, showing analternative embodiment of a surgical site visual indicator;

FIG. 26 is a perspective view of an embodiment of the locking pin membercontaining a data capture and/or display device;

FIG. 27 is a top view of an embodiment of the locking pin membercontaining an alternative embodiment of a data capture and/or displaydevice;

FIG. 28 is a perspective view of an embodiment of the locking pin membercontaining a data capture and/or display device and flash drive;

FIGS. 29A and 29B illustrate a flow chart describing an representativeembodiment of a method of preventing a wrong-site error during surgeryin accordance with the present invention;

FIG. 29C and FIG. 29D illustrate a flow chart describing anrepresentative embodiment of a method of preventing and tracking awrong-site error during surgery in accordance with the presentinvention;

FIG. 29E is an illustrative example of one or more biometric componentsof a system for collecting data to provide or update a wrong sitesurgery electronic profile;

FIG. 29F is an illustrative example of the one or more components of asystems for collecting data of patients as he/she moves within a medicalenvironment in order to populate and update a wrong site surgeryelectronic profile;

FIG. 29G is an illustrative example of the components that provide fordata collection or patient data confirmation as the patient navigatesthe surgical procedure environment;

FIG. 30 is a schematic illustration of a surgical system which utilizesa surgical container in accordance with the present invention;

FIG. 31 is a perspective view of a container for surgical equipmentaccording to an alternative embodiment of the invention;

FIG. 32 is an alternative perspective view of the container illustratedin FIG. 31;

FIG. 33 is a top view of the container illustrated in FIG. 31;

FIG. 34 is a bottom view of the container illustrated in FIG. 31;

FIG. 35 is side view of the container illustrated in FIG. 31;

FIG. 36 is an alternative side view of the container illustrated in FIG.31;

FIG. 37 is a front view of the of the container illustrated in FIG. 31;and

FIG. 38 is a back view of the container illustrated in FIG. 31.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

Referring to the drawing figures, the present invention includes asurgical system and a method of using the surgical system to impose apre-operative assessment to prevent wrong-site surgeries. The systemincludes a container that holds one or more surgical implements neededfor the surgery, a lock mechanism that secures the container in a closedposition, and a confirmation and/or signature label in a position thatprevents or at least impedes access to the lock. In this way, thesurgical team is forced to pause to deal with the label in order toaccess the surgical implements needed to start the surgery.

Referring to FIGS. 1-11, where is illustrated a surgical system 10according to a first example embodiment of the present invention. FIGS.1-4 show the surgical container 12, the lock mechanism 14, and theconfirmation and signature label 16 of the surgical system 10. Thecontainer 12 has a bottom 18 and a top 20 that can be positioned in theclosed position of FIG. 1 or the opened position of FIG. 4. In thedepicted embodiment, the top 20 and the bottom 18 slide relative to eachother to open and close the container 12. For example, the container 12may include a lip-and-groove arrangement 22 to permit the top 20 to beslid off of the bottom 18. In addition, the container 12 may includedetents or other structures for snapping closed the top 20 and bottom 18so that the container cannot freely slide open when it is unlocked. Inalternative embodiments, the container has a hinge for a pivotal openingmotion, preferably with the hinge permitting the top to be separatedfrom the bottom. The size of the container 12 is selected basedprimarily on the intended contents and may be customized for differenttypes of surgeries and/or different surgeons. In general, though, thecontainer 12 is not too large to be obtrusive or too small to escapenotice. In a typical commercial embodiment, the container 12 is about1-2 inches high, about 4-6 inches wide, and about 8-10 inches long. Inaddition, the container 12 is preferably generally rectangular withscalloped top edges for ease of gripping, and is preferably made of aplastic material, though other materials may be suitably employed.

Preferably, the bottom surface of the bottom 18 and the top surface ofthe top 20 are provided with gripping features so that they will notslip on a substantially horizontal surface they are resting upon. Forexample, the gripping features may include a layer 13 of frictionalmaterial such as rubber or soft plastic inlayed or applied onto the topsurface (or a portion thereof) of the top 20, and an adhesive-backed pad15 of frictional material such as rubber or soft plastic attached to thebottom surface of the bottom 18. In this way, the bottom 18 and theinverted top 20 are held in place during use, as described in detailbelow.

Referring additionally to FIGS. 5 and 6, the lock mechanism 14 securesthe container 12 in the closed position. The lock mechanism 14preferably includes a lock member that is received in locking engagementthrough two aligned lock openings in the top and bottom of thecontainer. For example, in the depicted embodiment the lock member 24linearly slides into a first lock opening 26 in the top 20 and a secondlock opening 28 in the bottom 18 when the container 12 is in the closedposition. The lock member 24 preferably includes a lock pin 32 that isreceived in the aligned openings 26 and 28 and a tab 34 for ease ofgrasping by hand. The top 20 may have a recess 36 configured to at leastpartially receive the tab 34 to provide a low profile, with the firstlock opening 26 positioned within the recess. The second lock opening 28is preferably formed into one or more divider walls 38 that definecompartments in the bottom 18, so that the opening is out of the way andso a separate upstanding structure is not required for defining theopening. The lock member 24 can be made of a plastic, metal, or othermaterial. It will be understood that other types of lock mechanisms maybe used to accomplish the herein-described purposes.

Referring additionally to FIGS. 7-9, the confirmation and signaturelabel 16 is removable and covers the lock member 24 so it cannot beaccessed to unlock the container 12 until the label is removed. In atypical commercial embodiment shown in FIG. 8, the confirmation andsignature label 16 has a front side that can be written upon and thatincludes a checklist to be filled out by the surgical technician, andfields where surgical team members sign after confirming that theinformation entered in the checklist is correct. For example, thechecklist preferably provides for confirming the correctness of thepatient name, the type/name of the surgical procedure, the laterality ofthe incision (left, right, or midline), and the laterality of thepathology (left, right, or midline), and for confirming that the properinstrumentation and any surgical implants are present and accounted for.It will be understood that the confirmation and signature label 16 maybe customized for the same or other surgical uses, and thus is notlimited to the specific representation depicted herein. Thus, inalternative embodiments, the checklist may call for the samesurgery-related information of the depicted embodiment, only some ofthis information, or additional information. Preferably, theconfirmation and signature label 16 is adhesive-backed and has a pulltab so that it can be easily removed from the container 12 and, ifdesired, placed in the medical record (the patient's record/chart/file)after it has been signed and removed.

In addition, the container 12 preferably has instructions for useprominently displayed on it. For example, in the depicted embodiment theinstructions are marked on an adhesive-backed label 40 that is appliedto the container top 20. Alternatively, the instructions may be printedor otherwise marked directly on the container 12 or elsewhere, or theymay be omitted.

Referring additionally to FIG. 10, the container 12 preferably has anadhesive-backed label 42 applied to the container top 20 to cover andhold a pen 44 within a recess 46 formed in the container top 20. The pen44 preferably has two marking tips 48 and 50 at opposing ends. A writingtip 48 is similar to a conventional ink pen for filling in and signingthe confirmation and signature label 16. And a surgical tip 50 issimilar to a conventional surgical pen with indelible ink forpre-operatively marking the surgical site on the patient's body, andoptionally for the signature of the surgeon. In alternative embodiments,the pen 44 may be removably attached to the container 12 byhook-and-loop fasteners or other conventional attachment structures; thepen 44 may be a conventional one-tipped ink or surgical pen, or it maybe omitted. In addition, a small measuring ruler may be included in therecess 46 or provided (e.g., etched, printed, or otherwise applied) onthe container, for example, at location 52 (FIG. 4).

The bottom 18 of the container 12 preferably includes a number ofinternal compartments (collectively referred to as the compartments 54)defined by the internal divider walls 38. The size, shape, andconfiguration of the compartments 54 are selected for the surgicalimplements desired to be held in the container 12, and as such may becustomized depending on the surgery and the surgeon. In the depictedembodiment, the container 12 has a first compartment 54 a that ispre-loaded with a syringe 56 containing a local anesthetic such aslidocaine, and a second compartment 54 b that is pre-loaded with one ormore surgical blades 58, such as Number 10 and 15 scalpels. It will beunderstood that the container 12 may be provided with both the syringe56 and the blades 58, with only one of these, and/or with other surgicalimplements such as packets of surgical needles. In alternativeembodiments, the compartments are sized, shaped, and configured forincluding other types of blades, handles for the blades, disposablesingle-unit scalpels, a syringe with another local anesthetic,arthroscopic probes, and/or other surgical implements needed to startthe case. In addition, the second compartment 54 b for the blades 58 mayhave a sheet of foam lining.

Referring additionally to FIG. 11, the depicted container 12 has a thirdcompartment 54 c and a fourth compartment 54 d that are sized, shaped,and configured for storing used syringe and suture needles 60 and 62after they have been used in the surgery. The compartments 54 c and 54 dare preferably each lined with an attachment sheet 64 and 66 that holdsthe used needles in place and that has numbered spaces for ease incounting the used needles. For example, the attachment sheet 64 and 66may be made of a foam and/or magnetic material. In addition, the firstcompartment 54 a can be used for miscellaneous purposes such as holdingunused suture packages 68 so they are readily accessible as neededduring the surgery. Thus, it will be noted that the container bottom 18of FIG. 10 is shown just opened and ready for use, and the containerbottom 18 of FIG. 11 is shown in the midst of use during the surgery.

A method of using the system 10 to prevent wrong-site surgeries will nowbe described. The container 12 is provided in the closed, lockedposition of FIGS. 1-3, preloaded with one or more surgical implementsneeded to start the surgery. The confirmation and signature label 16prevents accessing the lock member 24, so the surgical team must dealwith the label before it can unlock and open the container 12 to startthe surgery. This effectively forces a pause or “time out” before thesurgery can commence, thereby prompting the pre-operative assessment. Atthis time, the surgical technician who is starting the case fills outthe checklist on the label 16. For example, when using the confirmationand signature label 16 of FIG. 8, the surgical technician checks for thecorrect patient being present, the correct type/name of the surgicalprocedure, the correct laterality of the incision (left, right, ormidline), the correct laterality of the pathology (left, right, ormidline), and the presence of the proper instrumentation and/or neededsurgical implants. The attending surgeon then confirms all theinformation written on the confirmation and signature label 16 by thesurgical technician and signs his name to indicate that he/she haspersonally reviewed and confirmed the information to be correct. Thenthe surgeon (or the technician) removes the confirmation and signaturelabel 16 from the container 12, removes the lock member 24 (or otherwiseactuates the lock mechanism to unlock the container), and opens thecontainer 12 (see FIG. 4) to access the surgical implements in thecontainer. The removed confirmation and signature label 16 can be placedin the medical record to document that the “time out” and confirmationwas performed. At this point, the surgery start time is recorded, andsurgery is considered started.

The individual hospital's operating room policy preferably requires theoperating/attending surgeon to open the box him/herself, and/or to signhis/her name prior to making incision. In this way, the system 10 forcesthe surgical team to pause at the same time in every case (namely, justprior to incision), to ensure that the correct surgery is being done, onthe correct side, to the correct patient, and that all needed surgicalinstrumentation or implants are available. It will be understood thatother surgical systems that include a container for surgical implementsand a confirmation and/or signature label that is positioned to block orimpede opening of the container to force a pause just before the startof a surgery, but not specifically described herein, may be used withthe system to accomplish the functionality described herein. It shouldalso be noted that the system 10 is not meant to replace currentpre-operative measures to prevent wrong-site surgery (Le., all ofJHACO's advice/recommendations), though it could, but rather it isdesigned to supplement those measures by providing a last chance toprevent wrong-site surgery by forcing the pause just before theincision.

The uniqueness of the system 10 provides additional safety features. Oneof these safety features relates to the “neutral zone,” which isgenerally considered to be the area between the surgeon and the surgicaltechnician, where the surgeon's hands and the surgical technician'shands are supposed to never meet. But in practice, this is a general andundefined area, and it can expand, shrink, and shift as the surgeon andtechnician lean over, turn slightly to one side, and/or shift theirweight during the course of the surgery. Because of this, and because ofthe focus on the patient and the surgical procedure, occasionally thesurgeon and technician stick each other when passing sharp instrumentsback and forth.

Referring additionally to FIG. 12, after the container 12 has beenopened to start the surgery, the container top 20 may be inverted andplaced on a cart or other horizontal surface between the surgicaltechnician 70 and the surgeon 72 as they face the operating table 74. Asdescribed above, the top surface of the container top 20 and the bottomsurface of the container bottom 18 preferably have gripping features sothat they do not slip and move during the surgery. In this position, thecontainer top 20 defines a clearly demarcated, lateral neutral zone 76where hands are not allowed to meet. When the surgeon 72 is done with asharp instrument, he can simply place it in the neutral zone, that is,in the upside-down container top 20. The surgical technician 70 canlikewise add or remove sharp instruments to or from the invertedcontainer top. By the surgeon 72 and the surgical technician 70 neveractually handing each other sharp instruments, but instead having aclearly defined neutral zone 76 for indirectly passing sharps to eachother, the incidence of needle sticks can be reduced.

Furthermore, the container bottom 18 may be placed on a cart or otherhorizontal surface beside the surgical technician 70 (e.g., on theopposite side of the container top 20) or elsewhere in a position thatis convenient for the technician. With the container bottom 18accessible to the technician 70, he/she can use the container bottomduring the surgical case to store all the used sharps (e.g., scalpels,needles), as shown in FIG. 11, similarly to how the technician wouldnormally use a conventional sharps box or needle holder or counter. Thecontainer 12 or at least its top 20 may be red in color, similar to aconventional sharps box, to help minimize the likelihood of needlesticks. Alternatively, another color such as purple or opaque may beused.

Moreover, at the end of the case, all the sharps used during the surgerycan be put in the container 12, and the container can be closed andsafely disposed of. The detents or other snapping structures of thecontainer 12 hold the container closed. In addition, the lock mechanism14 may be provided with detents or other snapping structures so that thelock member can be reinserted to secure the container 12 closed. Thisway, all of the surgical sharps used during the case can be safelydisposed of as a single unit.

Turning now to FIGS. 13 and 14, there is illustrated a surgical system110 according to a second example embodiment of the present invention.Similarly to the system 10 of the first example embodiment, the system110 includes a container 112 with a bottom 118 and a top 120, a lockmechanism having a lock member 124 that is received in alignable firstopening 126 (not shown) and second opening 128, and a number of dividerwalls 138 forming compartments 154 for the surgical implements. In thisembodiment, however, compartment 154 b extends all the way across thecontainer bottom 118, and compartments 154 a, 154 c, and 154 d each havethe same length. In addition, the foam sheet inserts 64 and 66 for thecompartments are configured for the different arrangement of thecompartments.

Turning now to FIG. 15, there is illustrated a surgical system 210according to a third example embodiment of the present invention. Thesystem 210 is similar to that of the above-described embodiments, havinga container 212 with a bottom 218 and a top 220 and a confirmation andsignature label 216. In this embodiment, however, the label 216 ispositioned extending across the bottom 218 and top 220 of the container212 to hold it closed. In this way, the label 216 also functions as thelock mechanism, so a separate lock mechanism is not included. In use,after the label 216 is filled out, signed, and removed from thecontainer 212, the container can be opened to start the case withoutadditionally having to remove a separate lock member.

Turning now to FIG. 16, there is illustrated a surgical system 310according to a fourth example embodiment of the present invention. Thesystem 310 is similar to that of the first embodiment, having acontainer 312 with a bottom 318 and a top 320, and a lock mechanism 314with a lock member 324 received in two alignable lock openings 326 and328. In this embodiment, however, the lock member is a plastic tie wrapor a twisty tie, and the alignable lock openings 326 and 328 are definedin tabs extending from the exterior of the container. In addition, thesystem 310 may include a spare tie 324 for relocking the container 312after use for safe disposal. In an alternative embodiment, the lockmechanism is provided by a conventional slide-lock or snap-lockmechanism similar to that of commercially available surgical sharpsboxes.

Turning now to FIGS. 17 and 18, there is illustrated a surgical system410 according to a fifth example embodiment of the present invention.The system 410 is similar to that of the second embodiment, having acontainer 412 for surgical implements and a confirmation and/orsignature label 416 for use and removal just prior to starting thesurgery. In this embodiment, however, the lock mechanism is provided asa wrapper 414 with the label 416 on it. The wrapper 414 is preferablymade of a clear plastic material and has a circumferential opener strip415 a with a pull tab 415 b formed into it, similar to the wrapper,opener strip, and red pull tab on some conventional compact disc cases.The label 416 is preferably positioned on the wrapper 414 over the pulltab 415 so that when the label is peeled off, the pull tab 415 b ispulled and the opener strip 415 a is pulled to partially open thewrapper. The label 416 can be sized and shaped so that it wraps all theway, or most of the way, around the container 412, so that in order toremove the wrapper 414, the label must first be removed, therebyprompting the pause for the pre-operative assessment.

In the embodiments described herein, all of these components aresterilized so that the surgeon can sign the label at the operating tableimmediately prior to starting the surgery. To maintain the wrapper insterile condition, a removable outer wrapper 478 is preferably providedthat encloses the sterile components, as shown in FIGS. 17 and 18.

In other example embodiments, the system is provided with a containerfor surgical implements and a confirmation and/or signature labelremovably attached to the container, but without a lock mechanism forthe container or with a lock mechanism that is not covered by the label.Instead, the label is positioned directly or indirectly on the containerto merely impede opening the container; that is, the label is in aprominent position so that it is not easily overlooked and it therebyprompts the surgical team to conduct the pre-operative assessment. Suchembodiments are provided by the first example embodiment modifiedwithout the lock mechanism, and the fourth example embodiment modifiedwith the label on the container top only.

In still other alternative embodiments, the system includes a containerwith a scalpel (or other surgical implement) in it, with another way offorcing a pause without filling out a label. For example, the system caninclude a lock mechanism for the container that by itself forces thepause. The lock can be a small combination lock, with a combination thatonly the circulating nurse knows. The doctor and scrub tech confirm thatthey have the right patient and the right operation, and relay thatinformation to the circulating nurse, who then confirms the informationand gives them the code to open up the combination lock.

Referring to FIGS. 19A-25, an alternative embodiment of a surgicalsystem in accordance with the present invention is described. Thesurgical system 500 has many similarities to that of the above-describedembodiments. The surgical system 500 contains a container 512 which ispreferably adapted to be trackable and/or can electronically communicatewith other components of the system 500. The ability to be trackableand/or electronically communicate with other components of the system500 allows the users of the surgical procedure the ability tocontinuously monitor and check that the scheduled surgical proceduresfor a patient is correct, thereby extending the prevention of wrong sitesurgeries to multiple patient-medical representatives interactions.

The container 512 has a top 514 and a bottom 516 secured together toprovide an interior compartment. The interior compartment is designed tohold surgical instruments, such as described in FIG. 4, 10, or 11. Theinterior compartment is designed to hold pre-loaded surgical instrumentsspecific for each surgical procedure. As part of the system 500, one ormore labels, similar to the labels as described previously, for examplelabel 16 described and illustrated in FIG. 8. The label must allow atleast the surgeon, or other surgical team members, to fill in thesurgical-site information within an input field of the label, i.e. thesurgical-site information to conduct a pre-surgery assessment confirmingthe correct surgical site.

The container 512 has a locking mechanism, illustrated herein as a pinmember 518 sized and shaped to slidably engage and/or be positionedwithin the top 514 where at least a portion of the pin member 518 issecured within an opening positioned within the bottom 516, as describedin FIGS. 4-6. Alternative mechanisms for locking the container 512 mayinclude conventional slide-lock or snap-lock mechanism similar to thatof commercially available surgical sharps boxes or other previouslydescribed mechanisms. Whatever mechanism locks the container 512, thelabel must cover and/or prevent the locking mechanism from opening priorto the removal of the label. To aid the user in signing the label, thetop 514 of the container 512 may contain a recessed holding area 520sized and shaped to hold a writing utensil, such as a pen 522. To retainthe pen 522 within the recessed holding area 520, a writing utensillocking member, illustrated herein as two parallel and spaced apartfinger-like extensions 524 and 526, are secured to the bottom surface527 of the recessed holding area 520. The finger-like extensions 524 and526 have some elasticity so that when the pen 522 is inserted betweenthe two finger-like extensions 524 and 526, both move apart. Once thepen 522 is fully inserted within, the finger-like extensions 524 and 526snap back to their original position, securing the pen 522 in place.

To allow for monitoring and/or tracking, positioned on or with thecontainer 512 is a tracking and/or monitoring mechanism using, forexample, a data capture and/or display device or system or other digitalinformation options, illustrated herein as a bar code (an opticalmachine-readable representation of data) 528 preferably a UniversalProduct Code (UPC). The UPC can be programmed with various patientidentifying information similar to that of the labels describedpreviously, including the patient name or other identification means,type of surgery, site of surgery, and physician name. As such, when aphysician or medical support team member scans the bar code 528 with abar code reader or scanner, they will be able to view the information.Alternatively, the container may use a two dimensional bar code, such asa Quick Response Code (QR code), which is adapted to be read by animaging device, such as a camera.

Referring to FIG. 21, the container 512 is shown using an alternativeembodiment of a tracking and/or monitoring mechanism using, for example,a data capture and/or display device or system, illustrated herein as aradio-frequency identification (RFID) transponder 530. The RFIDtransponder 530 generally comprises a chip for storage and/orprocessing, an antenna for transmitting and receiving information, andan inlay for supporting the chip and antenna. While any RFID transponderknown to one of skill in the art may be used, the RFID transponder 530may be an active tag having a battery which runs the microchipcircuitry, or a passive tag without a battery and using a RFID readerwhich is designed to send electromagnetic waves to induce the tag'santenna to power the microchip circuitry. The transponder 530 may be aread-only tag which contains data pre-written thereon, a write-once tagwhich allows the user to write data to the tag one time, or a full readand write tag which enables the user to write new data to thetransponder as needed.

The inlay may be a substrate film which can support and hold the chipand antenna. Alternatively, the inlay can be a label or tag having selfadhesion coating to ensure that the RFID chip and antenna adhere to asurface. The inlay may be embedded in plastic castings or casted inpolyurethane resin coatings.

FIGS. 22-25 illustrate examples of the container 512 having additionalfeatures. FIG. 22 shows the container 512 having an additional recessedstorage area 532 adapted to store a data storage device, illustratedherein as a flash drive 534. The flash drive 534 preferably containsinformation relating to the patient that can be transported wherever thecontainer 512 travels, i.e. from the initial pre-op discussion to thesurgical room. FIGS. 23A and 23B illustrates a container 512 convertedto a “smart” container. The top 514 is adapted to include a centralcontrol unit 536 including, for example, a processor 538, memory 540,graphic processing unit 542, GPS functioning 544, and Bluetooth wirelesscapability 546. The central control unit 536 can be powered by a battery550 and electrically connected to a display unit 552, such as an LEDscreen 554, see FIG. 23A. Data input devices, such as buttons 558 or akeyboard (not shown), may be included to allow the user to input data.The container 512 may also contain a connection point, illustratedherein as a USB port 560 to allow for transfer of data from the centralcontrol unit 536 to a flash drive or a computer system via cables.

FIGS. 24 and 25 illustrate rapid identification features of thecontainer 512. As part of the overall surgical system 500, thecontainers are designed to provide easy and rapid visualization using avisual indicator to alert the surgical team as to which side (left orright), sometimes referred to as “laterality”, of the patient a surgicalprocedure is to take place. As shown in FIG. 24, the container 512includes all or at least a portion of the top 514, the bottom 516, andthe locking pin 518 having a color coding of some shade of red,illustrated herein as pink/rose color hash markings, to indicate a rightside surgical procedure. The locking mechanism is preferably colored aswell. FIG. 25 illustrates the container 512, and locking pin 518, havinga left side surgical procedure indicator, illustrated as a purple basedcolor, see broken line hatchings, preferably a lavender color.Alternative visual indicators may include symbols, letters, words orphases. In any embodiment, the surgeon or surgical team member caneasily ensure that the position of the surgical site or lateralityaligns with the color of the container 512.

FIGS. 26-28 illustrate the pin member 518 adapted to contain additionalfeatures that enhance the tracking and/or can electronic communicationwith other components of the system 500. As illustrated in FIG. 26, thetab 560 contains a bar code 528 secured to the side surface 562. FIG. 27illustrates a top view of the pin member 518 showing an RFID transponder530 secured to the top surface 564. FIG. 28 illustrates the pin member518 having a tab recessed receiving area 566 sized and shaped to receivea data storage device such as flash drive 534.

With the ability to track and/or communicate with other components ofthe surgical system, the container 512 can be used in multiple timeperiods within the entire surgical procedure, includingpre-hospitalization/surgical period, the day of pre-surgical procedurein the pre-op holding area, and the actual operating room. The systems,devices and methods in accordance with the present invention aredesigned to prevent wrong patient, wrong site, wrong side surgery byproviding multiple steps of protection at multiple time points when thepatient is passing through the surgical procedure environment, see FIGS.29A and 29B. As described herein, the use of the term “surgicalprocedure environment” or “surgical procedure” defines any period whenthe patient is interacting with his/her medical team or medical teamassociates including but not limited to office personnel, nurses,medical technicians, surgeons. The time period of interaction includespre-hospitalization and hospitalization, including pre, post and duringa surgical operation. The term may also include personnel involved withfinal data collection points such as a patient's insurance company,federal agency programs, such as Medicare/Medicaid that disburses fundsto the hospital as a method of payment or any other agency, private orfederal, which generates payment to the patient or patient's hospitalfor the specific surgical case.

Pre-Surgical Booking

Ensuring the prevention of wrong site surgeries begins as early as theinitial steps of the surgical procedure. At the time of surgicalbooking, errors can be initiated and perpetuated all the way through theactual surgical procedure. The system and methods of the presentinvention start when the surgeon's office schedules the surgery with thepatient, see step 610. At the time the surgery is scheduled by thehospital, the patient's name and information are associated with acontainer, preferably a trackable one such as container 512.

The container 512 may be provided with a unique container identificationnumber, similar to a vehicle identification number (VIN) used forautomobiles. The container identification number (CIN) may beestablished at the time of manufacture and remains with a particularcontainer. This number is unique to the container in that the number isnever reused and never applied to different containers. The uniqueidentification numbers can be integrally formed into the container ormay be attached to the container as part of a separate label, or part ofthe bar code or QR/Scan codes. Once the unique number is assigned to acontainer and/or is then further correlated or associated to aparticular patient, the container as well as the patient informationcoupled to it is serialized. This allows for the container to be trackedand analyzed as it moves through the medical system. In cases in which apatient has been determined to have wrong information, i.e. the patientshould have a right side surgery, but the box is coded for a left sidesurgery, the container is destroyed and the reason(s) for itsdestruction is electronically attached to the unique number. This allowsfor hospitals or manufactures to review all containers manufactured orscheduled for a medical procedure to determine how many were actuallyused in such surgical procedures. For those containers not used, reasonsas to why containers failed to be used in a medical procedure, potentialerrors (incorrect/inaccurate manual inputs), or wrong sitesurgeries/never events can be reviewed, providing insight as to when,where, and why surgical mistakes were made. Periodical reviews of suchdata allows hospitals to identify areas that need improvement.

If the patient is undergoing a surgical procedure which requires thesurgeon to perform a procedure on a particular side, a color codedcontainer 512, such as those described in FIGS. 24 and 25, is associatedwith the patient, see 614. For surgical procedures that do not requirelaterality, the container 512 will be a neutral color, such as gray.

Alternative embodiments of the medical system 500 may include the use ofa non-sterile outer box 521, see FIG. 19B having an upper portion 523securable to a lower portion 525 which houses the container 512.Preferably, the outer box contains tracking and/or electroniccommunications mechanisms, such as a bar code (including a QR code) orRFID tag. The outer box 521 may also be color coded to match the colorof the container 512. In this manner, the container 512 can betransported to various locations and/or handled by the surgical teamwhile on route to the operating room without concerns of contamination.In addition to color coding or matching, various patient relatedinformation, such as for example the patient's name, history, surgicalprocedure, side of surgery, associated color coding is encoded to anidentifying label or tag label, such as a bar scan.

At the time of the surgical procedure, the container 512 is delivered tothe patient at the pre-operation holding area, see 618. At this point,numerous opportunities are available to confirm that the patient willundergo the correct surgical procedure at the correct site, see 620.When the surgeon visits with the patient to discuss the surgery, andpossibly mark the site of surgery, the surgeon 622A and the patient 622Band will confirm the site of surgery. Additional surgical team membersmay also perform surgical procedure checks. For example, the prep nurse622C, and the operating room nurses 622D, may confirm the patient'sinformation is correct by matching the patient information to theinformation of the scan bar. As such, the surgeon 622A, prep nurse 622C,and the operating room nurses 62D may scan the bar code using a bar code(including a QR code) reader.

If the information matches, the patient continues with the medicalprocedure process. As part of the system 500, when a scan of the barcode/QR code is performed, the information may be displayed (i.e.surgical procedure for right side would be displayed with at least arose color that matches the rose color of the container 512) with amatching color background so that the medical professionals can easily,quickly visually confirm laterality. Determining or confirming surgicalprocedures and/or location at this point prevents any mistakes made atthe surgeons' office or by the hospital scheduler when scheduling theprocedure. In addition, all members of the surgical team are aware ofwhat procedure needs to be performed on the correct patient, and on whatside the procedure is to occur. If the surgeon or surgical team memberdetermines the surgery was not scheduled correctly, a new container 512with the correct information will be ordered and brought back to thepre-operation holding area, see 624.

Once the patient information has been determined to be correct, he/shewill be transferred to the operating room. At this point, the patientwill be checked in, see 626. At check in, patient information isverified and may be checked against the bar code information of thecontainer 512, see 628. The operating nurse will put in the informationin the electronic health record, see 630. Such step could be performedat a check in or sign in period. This information must match theinformation already in the electronic health records. If any informationis incorrect, the electronic health record can be put on hold, or on“freeze” so that any individual accessing the record would know that thepatient must not undergo any surgical procedures, see 632 and 634.

Once a determination has been made the information matches, i.e. it isthe correct patient, it is the correct surgery and correct surgicalsite, container 512 is presented to the surgeon, see 636. If thecontainer 512 is placed in an outer box, the surgeon simply removes theouter box and opens container 512. In either case, once the patient isprepped and draped, a formal and final timeout is performed by themembers of the surgical team, see 638. The surgeon fills in the label,see 640, either a label such as 16 or scans the bar code 530, placedover the locking mechanism of container 512 and pulls it off, see 642.The system 500 can be adapted to allow the surgeon to perform electronicsignatures, which can then be transferred to the patient's chart. If thecontainer 512 contains a flash drive or other memory storage device, thesurgeon or nurses could use such device to match the patient informationin the electronic health record. If any information does not match, afreeze could ensue, warning those involved with the surgery to stop anyfurther proceedings. He/she can now open the container 512 to gainaccess to the surgical equipment therein and begin surgery, see 644.

Referring to FIG. 29C and FIG. 29D, a representative embodiment of amethod of preventing and tracking wrong-site surgery near misses andwrong-site surgery errors, prior to, and during surgery, is described.Wrong-site surgery near miss and error data is collected to improvetactical decisions prior to surgery. As defined herein, “near miss data”refers to patient information that does not match with the patientprocedure. Such information can be a determination of wrong side ofsurgery, wrong site of surgery, or wrong patient. Such wrong informationwas determined before an actual procedure was done on the wrong side ofsurgery, the wrong site of surgery, or on the wrong patient. Anysurgical container (and its unique identification number) discarded as aresult of a determination of the wrong side of surgery, the wrong siteof surgery, or on the wrong patient wall be tracked and noted as part ofthe near miss data. Pauses, or stopping of a procedure and correctingmissing information can be tracked and included as near miss data. Thesystem and methods described herein, produce, capture, or store mineableelectronic wrong site surgery near miss and error data to supporthospital system analysis and process improvement, in order tosystematically decrease wrong site surgery errors across hospitalsystems and organizations. The method described utilizes many of thesame steps as described in FIGS. 29A and 29B (with like referencenumbers indicating the features of the steps described previously) withthe additional benefits of capturing wrong-site error data as a patientinteracts or moves with the surgical procedure environment. Accordingly,in combination with one or more of the previously described steps, themethod of preventing and tracking wrong-site errors during surgeryutilizes one or more of 1) patient biometric identifiers, 2) surgicalcontainer identifiers, 3) container tracking, preferably linked tocontainer identifiers, and 4) near miss wrong site surgical mistakes. Assuch, the method and system is designed to track and record events(patient scheduling, moving within the hospital system, time outs,incorrect information) and preferably electronically exports, such asinformation and patient outcome, to a digital or paper wrong sitesurgery record. The methods and systems utilized may include varioustechnologies, such as biometric readers, cameras, sensors, and trackingdevices positioned within the surgical procedure environment toelectrically capture various information as the patient moves within thesystem.

Information obtained by the electronic data created is used to provide awrong site surgical procedure electronic patient profile which can beused to identify when, where, or how a wrong site surgery occurred.Review of the data captured ensures key attributes of performing thecorrect surgery and at the correct patient site is completed properly,including performing a time out prior to surgery.

The system and methods of the present invention may start as early aswhen the surgeon's office schedules the surgery with the patient, step610. A wrong site surgical electronic profile is created for theindividual patient, see 646. The wrong site surgical electronic patientprofile 647 contains all necessary information which identifies thepatient, see 648 (FIG. 29E), including name, social security number,physical characteristics of height, weight, age, eye color, and haircolor, as well as other information required for the surgical procedureincluding type of surgery, laterality of surgical procedure, andphysician name. The wrong site surgical electronic patient profile 647is designed to continuously be updated with information related to thepatient as he/she moves from place to place. The wrong site surgicalelectronic patient profile 647 may be created and/or stored using acomputer system having a micro processor, data storage, memory, inputdevice, such as a keyboard, and a display unit, such as an LCD monitor.The wrong site surgical electronic patient profile 647 may also bedisplayed by other computer systems within the surgical procedureenvironment, such as in the operating room, at a nursing station, or ata patient's room. The wrong site surgical electronic patient profile 647may further include biometric authentication information 650, such asbut not limited to patient DNA 652A (see FIG. 29F), patient retinadisplay images 652B, patient iris scan 652C, face recognitioninformation 652D, fingerprint 652E, or combinations thereof. Additionalinformation related to the patient's movement within the surgicalprocedure environment 654 (FIG. 29E) may be obtained and used as part ofthe wrong site surgical electronic patient profile 647.

At the time the surgery is scheduled by the hospital, the patient'sname, information, and surgical profile are associated with a container,see step 612, preferably a trackable one such as container 512. Theassigned container 512 can be transferred with the patient from anypoint in the procedure to the operating room. Moreover, using trackingmethods such as RFID or GPS tracking, the device can be monitored andtracked in real time so conformation that the box is with the patient atall times can be accomplished and documented. The step of associatingcolor codes to the container, step 614, delivery of device to patientpre-op holding area, step 618, confirmation of surgical/surgery site,step 620, may be performed as described previously. Such information maybe obtained and recorded as part of the patient's wrong site surgicalelectronic patient profile 647. For instance, confirmation of thesurgical site, see 620, and any determination of incorrect informationrelating to the surgery, see 624, is recorded as part of the patient'swrong site surgical electronic patient profile 647. As the patient istransferred within the hospital setting, see step 654, confirmation ofpatient data related to the surgical site is obtained, see step 656, andpreferably recorded as part of the patient's wrong site surgicalelectronic patient profile 647. FIG. 29G illustrates various mechanismsas to how patient data related to the surgical site is obtained orconfirmed, including biometric data 658A using biometric devices (i.e.iris scans, device to obtain finger prints, data capture devices 658B,such as bar code scanners, sensors 658C, wireless data transfer systems658D, such as RFID systems, or cameras 658E. The camera 658E may providewrong site surgical electronic patient profile 647 using real-timeimages/videos 658F or recorded video images 658G. Patient implants,658H, such as embedded chips within a patient body to identify thepatient information, may also be used. Trackable surgical equipmenttagged with tracking devices 6581, such as RFID chips, may be includedas well. These devices or equipment may be positioned anywhere withinthe surgical procedure environment, and any information obtainedtherefrom forms the wrong site surgical electronic patient profile 647.

Once transferred to the operating room, see step 626, FIG. 29D, themethod of preventing and tracking wrong-site errors during surgeryincludes one or more steps, steps 628-644, as described previously. Oneor more of steps 628-644 can be used to form part of patient's wrongsite surgical electronic patient profile 647. For example, as thepatient is transported to the surgical operating room and theinformation is confirmed, whether via visual inspection, biometrics, ordata display or capture devices, all data obtained can be electronicallytransferred to the patient's wrong site surgical electronic patientprofile 647. In addition, the final time out, step 638, performed by thesurgeon can also be noted and electronically transferred to thepatient's wrong site surgical electronic patient profile 647.

At each step of the process described in FIG. 29C and FIG. 29D, one ormore members of the surgical procedure environment, i.e. surgeon,surgical staff, hospital staff, may manually or electronically enterdecision of “GO” to indicate a specific step is to continue as allinformation and actions to be performed are correct at that specificstep; a decision of “NOGO” to indicate that information and actionsinvolved with that step have been identified as incorrect, or “PAUSE” toindicate there is incomplete information or it is unclear whetherinformation and actions are correct. A “PAUSE” temporarily halts theprocess until information and actions are determined to be correct. Anoverride may be used to continue. The process may be designed so that a“NOGO” or “PAUSE” indication freezes the patient's wrong site surgicalelectronic patient profile 647 until the situation is corrected,understood, or overridden.

Once the surgical procedure is complete, a final deposition, 660, to thepatient's wrong site surgical electronic patient profile 647 may beentered. The final deposition 660 includes information related to finalpayment. This tracking point includes a patient's insurance company orfederal program (i.e., Medicare), issues funds to the surgical center ordisburses payment to the patient or patient representative, or in thecase of wrong site surgical error, any compensation paid to the patientor settlement for damages associated with the wrong site surgery.

Referring to FIG. 30, the present invention is shown linked to a smartsurgery room. For example, the container 512 located in a surgical room700 may contain a container control panel such as control panel 554.Within the surgical room 700, an information reader, such as a RFIDreader 702 is located to read the RFID tag 530. The container controlpanel 554 is preferably electronically connected, via wired or wirelesstechnology, to a hospital or central control unit 704 having one orcentral computers 705 outside the surgical room 700. The control unitcould be a manned station functioning similar to a flight control tower.Alternatively, or in addition to, the container control panel 554 may bein electronic communication with a surgical room control unit 706 havingat least one computer 707 located within the room. Individuals manningthe control unit 704 may provide the surgeon within the surgical room700 clearance to proceed with opening the container 512 based on theinformation received from the container, using, for example, aradiofrequency device. Based on the information received, the containermay be opened remotely using an electronic lock 710 on the container512. Preferably, the lock would be electrically coupled or incommunication with the hospital control unit 704 and/or the surgicalroom control unit 706.

Additional features of the system may include container 512 and/or thesurgical equipment having LEDs attached thereto to allow for tracking byoptical or camera guided navigation systems. In addition to the abovedescribed features, it is understood that the container 512 may includeor be adapted to include one or more features described previously,whether as part of a system or as a feature of a container embodiment.

In addition to providing a timeout, the medical system 500 allows fortracking of errors from pre-hospitalization to the actual surgicalprocedure. This provides a hospital valuable data as to where errors orpossible errors may have occurred.

Accordingly, the present invention provides a number of advantages. Inparticular, the system and method of the invention insure a finalconfirmation of the correct patient, procedure, site, and as applicable,implants or instrumentation, is performed thoroughly and consistently,immediately prior to allowing incision to be made. The marking of thesurgical site, the required use and removal of the confirmationchecklist before accessing the surgical blades needed to start thesurgery, and the resulting open communication between the patient, thesurgeon, and the operating team, all contribute to reducing wrong-sitemedical errors. In addition, the surgical container provided by theinvention can be used as a needle box for sharps disposal at the end ofthe case, and as a neutral zone during the case to decrease theincidence of needle sticks or lacerations from the surgeon and thesurgical technician handing each other sharp instruments such asscalpels or needles. Furthermore, use of the invention can actually beextended to other areas of the hospital where an incision might be made,such as in the interventional radiology suite, the intensive care unit,or the emergency room.

Referring to FIGS. 31-38, an alternative embodiment of a container 810is shown. The container 810 has a top 814 and a bottom 816 securedtogether to provide an interior compartment. The interior compartment isdesigned to hold surgical instruments, such as described in FIG. 4, 10,or 11. The interior compartment is designed to hold pre-loaded surgicalinstruments specific for each surgical procedure. One or more labels,similar to the labels as described previously, for example label 16described and illustrated in FIG. 8, can be secured to the container810. The label must allow at least the surgeon, or other surgical teammembers, to fill in the surgical-site information within an input fieldof the label, i.e. the surgical-site information to conduct apre-surgery assessment confirming the correct surgical site.

The container 812 has a locking mechanism, illustrated herein as a pinmember 818, similar to pin 518, sized and shaped to slidably engageand/or be positioned within the top 514 where at least a portion of thepin member 818 is secured within an opening positioned within the bottom516, as described in FIGS. 4-6. A ring 819 is secured to or integrallyformed to the pin member 818, acting as a mechanism for grabbing andpulling the pin member 818 out. Alternative mechanisms for locking thecontainer 812 may include conventional slide-lock or snap-lock mechanismsimilar to that of commercially available surgical sharps boxes or otherpreviously described mechanisms. Whatever mechanism locks the container812, the label must cover and/or prevent the locking mechanism fromopening prior to the removal of the label.

To aid the user in signing the label, the top 814 of the container 812may contain a recessed holding area 820 sized and shaped to hold awriting utensil, such as a pen 822. To retain the pen 822 within therecessed holding area 820, a writing utensil locking member, illustratedherein as two parallel and spaced apart finger-like extensions 824 and826, are secured to the bottom surface 827 of the recessed holding area820. The finger-like extensions 824 and 826 have some elasticity so thatwhen the pen 822 is inserted between the two finger-like extensions 824and 826, both move apart. Once the pen 822 is fully inserted within, thefinger-like extensions 824 and 826 snap back to their original position,securing the pen 822 in place. A plurality of vents, 828, are used toallow for release substances, such as heat/steam when the device issterilized. Adjacent to the recessed area 820, is a second or extendedrecessed area 830 which contains a securing mechanism, illustratedherein as a compression member 832 which may be used as a compressionpoint for surgical equipment, such as surgical blades stored thereunder.

In addition to the above described features, it is understood that thecontainer 810 may include or be adapted to include one or more featuresdescribed previously, whether as part of a system or as a feature of acontainer embodiment including but not limited to monitoring and/ortracking or color coding features.

It is to be understood that this invention is not limited to thespecific devices, methods, conditions, or parameters described and/orshown herein, and that the terminology used herein is for the purpose ofdescribing particular embodiments by way of example only. Thus, theterminology is intended to be broadly construed and is not intended tobe limiting of the claimed invention. For example, as used in thespecification including the appended claims, the singular forms “a,”“an,” and “the” include the plural, the term “or” means “and/or,” andreference to a particular numerical value includes at least thatparticular value, unless the context clearly dictates otherwise. Inaddition, any methods described herein are not intended to be limited tothe sequence of steps described but can be carried out in othersequences, unless expressly stated otherwise herein.

While the invention has been described with reference to an exampleembodiment, it will be understood by those skilled in the art that avariety of modifications, additions and deletions are within the scopeof the invention, as defined by the following claims.

What is claimed is:
 1. A method of preventing or tracking a wrong-siteerror during surgery comprising: identifying an individual in need of asurgical procedure; providing a wrong site surgical procedure electronicprofile for said individual, said wrong site surgical procedureelectronic profile associated with said surgical procedure to beperformed on said individual; associating said wrong site surgicalprocedure electronic profile to a surgical container containing surgicalinstruments for said surgical procedure, said surgical containerconfigured to contain at least a removable label including a checklistfor confirming surgery-related information and one or more fields forsignatures positioned on said surgical container to prevent or impedeaccess to said surgical instrument stored therein and a data capture ordata display device; tracking said wrong site surgical procedure statusof said patient as said patient moves within a surgical procedureenvironment; updating said electronic profile as said individual movesthrough said surgical procedure environment.
 2. The method of preventinga wrong-site error during surgery according to claim 1 further includingthe step of providing a final report after said individual has completedmovement within the surgical procedure environment.
 3. The method ofpreventing a wrong-site error during surgery according to claim 1further including the step of associating a visual indicator to saidcontainer, said visual indicator providing a user visual confirmation asto a site on said individual where the surgical procedure should occur.4. The method of preventing or tracking wrong-site error during surgeryaccording to claim 1 wherein said visual indicator is a color coding,wherein said color indicates a procedure on an anatomical part on theleft side, right side, or no lateral side of said individual in need ofa surgical procedure.
 5. The method of preventing or tracking awrong-site error during surgery according to claim 1 further includingthe step of associating said container with said patient in need of asurgical procedure occuring when said patient is scheduled for asurgical procedure.
 6. The method of preventing or tracking a wrong-siteerror during surgery according to claim 1 further including the stepsof: at the site of surgery, obtaining said container; verifying acorrect surgical site and filling in the surgical-site information inputfield of the label with the surgical-site information to conduct apre-surgery assessment confirming the correct surgical site; removingthe label from the container and saving it as a medical record for laterdocumentation that the pre-surgery assessment confirming the correctsurgical site was in fact conducted; opening the container and removingthe at least one surgical implement, and using the at least one surgicalimplement at the outset of the surgery, wherein the pre-surgeryassessment confirming the correct surgical site is timely conductedbefore opening the container, removing the at least one surgicalimplement, and starting the surgery with the at least one surgicalimplement, wherein timely conducting the pre-surgery assessment isprompted by the label being positioned to prevent or at least impedeopening the container, and wherein the initial position, input field,and removal of the label effectively accomplish the dual purposes offirst forcing the prompt for the pre-surgery assessment and then seconddocumenting that the pre-surgery assessment in fact was conducted. 7.The method of preventing or tracking a wrong-site error during surgeryaccording to claim 1 wherein said step of verifying a correct surgicalsite includes obtaining data from said data capture and/or displaydevice.
 8. The method of preventing or tracking a wrong-site errorduring surgery according to claim 1 further including the step ofassociating biometric data with said wrong site surgical procedureelectronic profile.
 9. The method of preventing or tracking a wrong-siteerror during surgery according to claim 8 wherein said biometric dataassociated with said wrong site surgical procedure electronic profileincludes fingerprint data, face recognition data, iris recognition data,retina scan data, DNA data, or combinations thereof.
 10. The method ofpreventing or tracking a wrong-site error during surgery according toclaim 8 further including the steps of obtaining biometric data of assaid patient moves within said surgical procedure environment; andupdating said wrong site surgical procedure electronic profile with saidupdated biometric data.
 11. The method of preventing or tracking awrong-site error during surgery according to claim 1 further includingthe step of obtaining wrong site surgical data on said patient as saidpatient moves through said surgical procedure environment.
 12. Themethod of preventing or tracking a wrong-site error during surgeryaccording to claim 1 further including the step of obtaining wrong sitesurgical data on said patient as said patient movies through saidsurgical procedure environment; and modifying said wrong site surgicalprocedure electronic profile based on said updated wrong site surgicaldata captured as said patient moves within the surgical procedureenvironment.
 13. The method of preventing or tracking a wrong-site errorduring surgery according to claim 1 wherein said obtaining wrong sitesurgical data associated with said wrong site surgical procedureelectronic profile includes data obtained from a data capture device, asensor, a wireless data transfer device, a camera, or combinationsthereof.
 14. The method of preventing or tracking a wrong-site errorduring surgery according to claim 1 wherein said wrong site surgicalprocedure electronic profile includes real time data obtained from oneor more cameras, recorded data from said one or more cameras, orcombinations thereof.
 15. The method of preventing or tracking awrong-site error during surgery according to claim 1 wherein said wrongsite surgical procedure electronic profile contains verification that afinal timeout has been performed.
 16. The method of preventing ortracking a wrong-site error during surgery according to claim 1 whereinsaid wrong site surgical procedure electronic profile contains one ormore decision input indications that said surgical procedure occurred,said surgical procedure did not occur, or said surgical procedure waspaused.
 17. The method of preventing or tracking a wrong-site errorduring surgery according to claim 1 wherein said wrong site surgicalprocedure electronic profile contains final disposition of said surgicalprocedure, wherein said final disposition surgical procedure informationincludes indication that a final payment or disbursement of fundsoccurred.
 18. A system for preventing or tracking a wrong-site errorduring a surgical procedure, comprising: a container having a topportion containing a first locking portion adapted to engage with asecond locking portion, and a bottom portion containing a second lockportion adapted to engage with said first locking portion; one or moresurgical implements positioned within the one or more compartments; alock mechanism that secures the container in a closed position; aremovable label including a checklist for confirming surgery-relatedinformation and one or more fields for signatures, said label positionedwithin said container to prevent or impede access to at least a portionof said lock mechanism without first removing the label; and a datacapture and/or display device secured to at least one portion of saidcontainer.
 19. The system for preventing or tracking a wrong-site errorduring a surgical procedure according to claim 18 further including awrong site surgical procedure electronic profile.
 20. The system forpreventing or tracking a wrong-site error during a surgical procedureaccording to claim 18 wherein said data capture device uses opticalmachine-readable representation of data.
 21. The system for preventingor tracking a wrong-site error during a surgical procedure according toclaim 18 wherein said data capture device is a radio frequencyidentification transponder.
 22. The system for preventing or tracking awrong-site error during a surgical procedure according to claim 18wherein said top portion contains a first lock opening sized and shapedto receive a locking pin and said bottom portion contains a second lockopening sized and shaped to receive a locking member, said bottomportion adapted to slidably engage said top portion whereby said topportion and said bottom portion are movable between a closed positionand an open position, each said lock opening positioned within said topor bottom portion to form an overlapping orientation to receive saidlock member when in the closed position.
 23. The system for preventingor tracking a wrong-site error during a surgical procedure according toclaim 22 wherein said lock mechanism that secures the container in theclosed position comprises a locking pin having at least one portion forlinearly engaging said top and bottom portion when said container is insaid closed position.
 24. The system for preventing or tracking awrong-site error during a surgical procedure according to claim 18wherein said container is adapted to provide a visual indication forindicating a surgery site.
 25. The system for preventing or tracking awrong-site error during a surgical procedure according to claim 18wherein said visual indication is a color coding.
 26. The system forpreventing or tracking a wrong-site error during a surgical procedureaccording to claim 18 wherein said top or bottom portion includes one ormore compartments for holding surgical instruments.
 27. The system forpreventing or tracking a wrong-site error during a surgical procedureaccording to claim 18 further including biometric data of a patientelectronically linked to identification of said container.
 28. Thesystem for preventing or tracking a wrong-site error during a surgicalprocedure according to claim 19 further including one or more devicesfor capturing patient information.
 29. The system for preventing ortracking a wrong-site error during a surgical procedure according toclaim 28 wherein said one or more devices for capturing patientinformation is electronically linked to said wrong site surgicalprocedure electronic profile.
 30. The system for preventing or trackinga wrong-site error during a surgical procedure according to claim 18wherein said wrong site surgical procedure electronic profile includeswrong-site surgery near miss data, wrong-site surgery error data, orcombinations thereof.